Study study type PathologyT1T0Patientssample sizesROB Results

metastatic/advanced RCC (mRCC) - (neo)adjuvant(NA) metastatic/advanced RCC (mRCC) - (neo)adjuvant(NA)

versus placebo
pembrolizumab alone
KEYNOTE-564 unpublished
  NCT03142334
RCTmetastatic/advanced RCC (mRCC) - (neo)adjuvant(NA)pembrolizumabplaceboPatients (>=18yr), with histologically confirmed locoregional renal-cell carcinoma with a clear-cell component and with criteria for highr risk of recurrence.496 / 498NA
conclusif
  • suggested 46 % decrease in deaths (OS) (PE)
  • demonstrated 32 % decrease in RFS/DFS (PE)

metastatic/advanced RCC (mRCC) - 1st line (L1) metastatic/advanced RCC (mRCC) - 1st line (L1)

versus sunitinib
atezolizumab alone
IMmotion-150 (At - all population), 2018
  NCT01984242
RCTmetastatic/advanced RCC (mRCC) - 1st line (L1)atezolizumabsunitinibunresectable advanced or mRCC with a component of clear cell histology and/or sarcomatoid histology not previously treated with any systemic agents for RCC103 / 101some concern
inconclusive
  • inconclusive 19 % increase in progression or deaths (PFS) (PE)
atezolizumab plus bevacizumab
IMmotion-151 (all population), 2019
  NCT02420821
RCTmetastatic/advanced RCC (mRCC) - 1st line (L1)atezolizumab plus bevacizumabSunitinibpatients with unresectable locally advanced or metastatic renal cell carcinoma with any component of clear cell or sarcomatoid histology, with Karnofsky performance status 70% or higher.454 / 461high
inconclusive
  • inconclusive 7 % decrease in deaths (OS) (PE)
IMmotion-150 (AtB - all population), 2018
  NCT01984242
RCTmetastatic/advanced RCC (mRCC) - 1st line (L1)atezolizumab with bevacizumabsunitinibunresectable advanced or mRCC with a component of clear cell histology and/or sarcomatoid histology not previously treated with any systemic agents for RCC101 / 101some concern
inconclusive
  • inconclusive 0 % increase in progression or deaths (PFS) (PE)
avelumab plus axitinib
JAVELIN Renal 101 (all population), 2019
  NCT02684006
RCTmetastatic/advanced RCC (mRCC) - 1st line (L1)Avelumab plus AxitinibSunitinibpatients with previously untreated advanced renal cell carcinoma442 / 444some concern
conclusif
  • demonstrated 31 % decrease in progression or deaths (PFS) (PE)
  • suggested 31 % decrease in PFS (extension)
lenvatinib plus everolimus
KEYNOTE-581/CLEAR (mtor), 2021
  NCT02811861
RCTmetastatic/advanced RCC (mRCC) - 1st line (L1)lenvatinib plus everolimussunitinibfirst-line treatment of patients with previously untreated advanced renal cell carcinoma with a clear-cell component357 / 357some concern
conclusif
  • demonstrated 35 % decrease in progression or deaths (PFS) (PE)
nivolumab plus cabozantinib
CheckMate 9ER, 2021
  NCT03141177
RCTmetastatic/advanced RCC (mRCC) - 1st line (L1)Nivolumab and CabozantinibSunitinibpatients with previously untreated advanced or metastatic RCC that had a clear cell component323 / 328some concern
conclusif
  • demonstrated 40 % decrease in deaths (OS) (PE)
  • demonstrated 49 % decrease in progression or deaths (PFS) (PE)
  • suggested 30 % decrease in deaths (OS) (extension)
  • suggested 44 % decrease in PFS (extension)
  • more...
nivolumab (Opdivo) and cabozantinib (Cabometyx) demonstrated superior PFS, OS, and ORR compared with first-line sunitinib (Sutent) in patient with advanced clear cell renal cell carcinoma
nivolumab plus ipilimumab
CheckMate 214 (favorable risk) EXPLORATORY, 2017
  NCT02231749
RCTmetastatic/advanced RCC (mRCC) - 1st line (L1)nivolumab plus ipilimumabsunitinibpatients previously untreated advanced or metastatic renal cell carcinoma with a clear-cell component, with favorable risk (IMDCC)125 / 124some concern
inconclusive
  • statistically significant 1.2-fold increase in progression or deaths (PFS)
CheckMate 214 (all population), 2017
  NCT02231749
RCTmetastatic/advanced RCC (mRCC) - 1st line (L1)nivolumab plus ipilimumabsunitinibpatients previously untreated advanced or metastatic renal cell carcinoma with a clear-cell component550 / 546some concern
inconclusive
  • suggested 32 % decrease in deaths (OS)
  • suggested 29 % decrease in deaths (OS) (extension)
  • suggested 15 % decrease in PFS (extension)
CheckMate 214 (intermediate and poor risk), 2017
  NCT02231749
RCTmetastatic/advanced RCC (mRCC) - 1st line (L1)nivolumab plus ipilimumabsunitinibpatients previously untreated advanced or metastatic renal cell carcinoma with a clear-cell component425 / 422some concern
conclusif
  • demonstrated 37 % decrease in deaths (OS) (PE)
  • inconclusive 18 % decrease in progression or deaths (PFS) (PE)
  • suggested 34 % decrease in deaths (OS) (extension)
  • suggested 23 % decrease in PFS (extension)
  • more...
pembrolizumab plus axitinib
KEYNOTE-426, 2019
  NCT02853331
RCTmetastatic/advanced RCC (mRCC) - 1st line (L1)pembrolizumab plus axitinibsunitinibpatient newly diagnosed or recurrent stage IV clear-cell renal-cell carcinoma; had received no previous systemic therapy for advanced disease;432 / 429some concern
conclusif
  • demonstrated 47 % decrease in deaths (OS) (PE)
  • demonstrated 31 % decrease in progression or deaths (PFS) (PE)
  • suggested 32 % decrease in deaths (OS) (extension)
  • suggested 29 % decrease in PFS (extension)
  • more...
pembrolizumab plus lenvatinib
KEYNOTE-581/CLEAR (PDL1), 2021
  NCT02811861
RCTmetastatic/advanced RCC (mRCC) - 1st line (L1)lenvatinib plus pembrolizumabsunitinibfirst-line treatment of patients with previously untreated advanced renal cell carcinoma with a clear-cell component355 / 357some concern
conclusif
  • demonstrated 34 % decrease in deaths (OS) (PE)
  • demonstrated 61 % decrease in progression or deaths (PFS) (PE)
  • demonstrated 97 % increase in objective responses (ORR) (PE)
The combination of pembrolizumab (Keytruda) plus lenvatinib (Lenvima) significantly improved progression-free survival (PFS), overall survival (OS), and the objective response rate (ORR) compared with sunitinib (Sutent)

mRCC - L1 - PDL1 negative metastatic/advanced RCC (mRCC) - 1st line (L1) mRCC - L1 - PDL1 negative

versus sunitinib
atezolizumab plus bevacizumab
IMmotion-151 (PDL1 <1%) EXPLORATORY, 2019
  NCT02420821
RCTmRCC - L1 - PDL1 negativeatezolizumab plus bevacizumabSunitinibPatients with unresectable locally advanced or metastatic renal cell carcinoma with any component of clear cell or sarcomatoid histology (PDL1 negative patients)276 / 277high
inconclusive
    no statistically significant result

mRCC - L1 - PDL1 positive metastatic/advanced RCC (mRCC) - 1st line (L1) mRCC - L1 - PDL1 positive

versus sunitinib
atezolizumab alone
IMmotion-150 (At - PDL1>1%), 2018
  NCT01984242
RCTmRCC - L1 - PDL1 positiveatezolizumabsunitinibunresectable advanced or mRCC with a component of clear cell histology and/or sarcomatoid histology not previously treated with any systemic agents for RCC. Patients had PDL1 >1%54 / 60some concern
inconclusive
  • inconclusive 3 % increase in progression or deaths (PFS) (PE)
atezolizumab plus bevacizumab
IMmotion-151 (PDL1 >1%), 2019
  NCT02420821
RCTmRCC - L1 - PDL1 positiveatezolizumab plus bevacizumabSunitinibpatients with unresectable locally advanced or metastatic renal cell carcinoma with any component of clear cell or sarcomatoid histology178 / 184high
inconclusive
    no statistically significant result
IMmotion-150 (AtB - PDL1>1%), 2018
  NCT01984242
RCTmRCC - L1 - PDL1 positiveatezolizumab with bevacizumabsunitinibunresectable advanced or mRCC with a component of clear cell histology and/or sarcomatoid histology not previously treated with any systemic agents for RCC. patients with PDL1 >1% positive only50 / 60some concern
suggested
  • inconclusive 36 % decrease in progression or deaths (PFS) (PE)
avelumab plus axitinib
JAVELIN Renal 101( PDL1>1%), 2019
  NCT02684006
RCTmRCC - L1 - PDL1 positiveAvelumab plus AxitinibSunitinibpatients with previously untreated advanced renal cell carcinoma (PDL1>1% population)270 / 290some concern
conclusif
  • suggested 31 % decrease in deaths (OS) (PE)
  • demonstrated 39 % decrease in progression or deaths (PFS) (PE)
  • suggested 38 % decrease in PFS (extension)

metastatic/advanced RCC (mRCC) - 2nd line (L2) metastatic/advanced RCC (mRCC) - 2nd line (L2)

versus cabozantinib
atezolizumab plus cabozantinib
CONTACT-03, 2023
  NCT04338269
RCTmetastatic/advanced RCC (mRCC) - 2nd line (L2)atezolizumab plus cabozantinibcabozantinib alonePatients aged 18 years or older with locally advanced or metastatic renal cell carcinoma whose disease had progressed with immune checkpoint inhibitors263 / 259low
inconclusive
  • inconclusive 6 % decrease in deaths (OS) (PE)
  • inconclusive 3 % increase in progression or deaths (PFS) (PE)
versus everolimus
nivolumab alone
CheckMate 025, 2015
  NCT01668784
RCTmetastatic/advanced RCC (mRCC) - 2nd line (L2)nivolumabeverolimuspatients with advanced clear-cell renal-cell carcinoma for which they had received previous treatment with one or two regimens of antiangiogenic therapy410 / 411some concern
conclusif
  • demonstrated 27 % decrease in deaths (OS) (PE)
  • demonstrated 5.0-fold increase in objective responses (ORR) (PE)